A Study to Evaluate the Effects of Single and Multiple Oral Doses of GLPG3970

NCT04106297 | Completed Phase 1

• 2 other identifiers: GLPG3970-CL-1012019-001803-19
• Study Type: interventional
• Target: 100
• Locations: 3 countries
• Sites: 3

Brief Summary

The main purpose of this study is to evaluate the safety and tolerability of GLPG3970 in healthy volunteers after single oral administrations of GLPG3970 (SAD), compared to placebo (part 1 and 1bis) and after multiple (for 14 days) oral administrations of GLPG3970 (MAD), compared to placebo (part 2). The effect of food (FE) (high-fat, high calorie) on the pharmacokinetics of GLPG3970 and the relative bioavailability (rBA) of an oral solution versus a solid formulation will be assessed (part 3 and 3bis). Part 4 of the study is to evaluate the safety and tolerability of GLPG3970 in subjects with moderate to severe psoriasis when administered daily for 6 weeks.

Conditions

Healthy; Psoriasis

Outcome Measures

Primary Outcomes (1)

• Number of treatment emergent adverse events (TEAEs), treatment-emergent serious adverse events, and TEAEs leading to treatment discontinuations

  To evaluate the safety and tolerability of GLPG3970 compared to placebo in adult healthy male subjects as single and multiple ascending oral doses, and in subjects with moderate to severe psoriasis when administered daily for 6 weeks

  From screening through study completion, an average of 20 months

Secondary Outcomes (10)

• Maximum observed plasma concentration (Cmax) of GLPG3970 (Part 1 and 1bis)

  Between Day 1 pre-dose and Day 4

• Maximum observed plasma concentration (Cmax) of GLPG3970 (Part 2)

  Between Day 1 pre-dose and Day 17

• Maximum observed plasma concentration (Cmax) of GLPG3970 (Part 3 and 3bis, FE)

  Between Day 1 pre-dose and Day 4

• Maximum observed plasma concentration (Cmax) of GLPG3970 (Part 3, rBA)

  Between Day 1 pre-dose and Day 4

• Area under curve (AUC) of GLPG3970 (Part 1 and 1bis)

  Between Day 1 pre-dose and Day 4

Study Arms (8)

GLPG3970 SAD

EXPERIMENTAL

Single doses of GLPG3970 at up to 6 dose levels in ascending order

Drug: GLPG3970 oral solution

Placebo SAD

PLACEBO COMPARATOR

Single doses of placebo

Drug: Placebo oral solution

GLPG3970 MAD

EXPERIMENTAL

Multiple doses of GLPG3970 at up to 4 dose levels in ascending order, daily for 14 days

Drug: GLPG3970 oral solution

Placebo MAD

PLACEBO COMPARATOR

Multiple doses of placebo

Drug: Placebo oral solution

GLPG3970 FE-rBA

EXPERIMENTAL

Single dose of GLPG3970 in fed and fasted state

Drug: GLPG3970 oral solution; Drug: GLPG3970 capsule

GLPG3970 FE

EXPERIMENTAL

Single dose of GLPG3970 in fed and fasted state

Drug: GLPG3970 oral solution

GLPG3970 in psoriasis subjects

EXPERIMENTAL

Drug: GLPG3970 oral solution

Placebo in psoriasis subjects

EXPERIMENTAL

Drug: Placebo oral solution

Interventions

GLPG3970 oral solution DRUG

GLPG3970 for oral administration

GLPG3970 FE; GLPG3970 FE-rBA; GLPG3970 MAD; GLPG3970 SAD; GLPG3970 in psoriasis subjects

Placebo oral solution DRUG

Placebo for oral administration

Placebo MAD; Placebo SAD; Placebo in psoriasis subjects

GLPG3970 capsule DRUG

GLPG3970 for oral administration

GLPG3970 FE-rBA

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male between 18-55 years of age (extremes included), on the date of signing the informed consent form (ICF).
• A body mass index (BMI) between 18-30 kg/m2, inclusive.
• Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and fasting clinical laboratory safety tests available at screening and prior to randomization. Hemoglobin must not be below the lower limit of normal range. Bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) must be no greater than 1.5x upper limit of normal range (ULN). Other clinical laboratory safety test results must be within the reference ranges, or test results that are outside the reference ranges need to be considered not clinically significant in the opinion of the investigator.
• Male or female between 18-65 years of age (extremes included), on the date of signing the ICF.
• Diagnosed with plaque psoriasis ≥6 months.
• Screening Psoriasis Area and Severity Index (PASI) ≥12 (moderate to severe) and affected body surface area (BSA) ≥10%.
• A body mass index (BMI) between 18-35 kg/m2, inclusive.

You may not qualify if:

• Known hypersensitivity to the Investigational Medicinal Product (IMP) ingredients or history of a significant allergic reaction to IMP ingredients as determined by the investigator.
• Positive serology for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus or history of hepatitis from any cause with the exception of hepatitis A that was resolved at least 3 months prior to first dosing of the IMP.
• History of or a current immunosuppressive condition (e.g. human immunodeficiency virus \[HIV\] infection).
• Subject has evidence of skin conditions other than psoriasis (e.g., eczema) at the time of screening or baseline visit that would interfere with the evaluation of psoriasis.
• Subject is unable to discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot discontinue phototherapy (UVB or PUVA) from signing of the ICF up to the end of the study.

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (3)

SGS Belgium NV - Clinical Pharmacology Unit Antwerp

Antwerp, 2060, Belgium

Location

Clinical Republican Hospital Arensia Experimental Medicine

Chisinau, MD2025, Moldova

Location

ARENSIA Exploratory Medicine Unit

Kyiv, 01135, Ukraine

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Magdalena Petkova, MD

  Galapagos NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1 and 1bis (SAD), Part 2 (MAD) and Part 4 (psoriasis subjects) are randomized, double-blind, placebo-controlled; Part 3 (FE-rBA) and Part 3bis (FE) are randomized, open-label.

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: September 27, 2019
• Study Start: September 10, 2019
• Primary Completion: March 5, 2021
• Study Completion: March 5, 2021
• Last Updated: September 19, 2024

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1); MO (1); BE (1)